check_circleStudy Completed

Neoplasms

Bayer Identifier:

16821

ClinicalTrials.gov Identifier:

NCT02042144

EudraCT Number:

Not Available

EU CT Number:

Not Available
Safety and Effectiveness of Regorafenib

Trial purpose

This study is a prospective observational cohort study.
The study will be conducted in routine clinical practice
settings. It is planned to enroll 1000 patients with
metastatic Colorectal Cancer (mCRC) who have been
previously treated with other approved treatments for
metastatic disease and for whom a decision has been
made by the physician to treat with regorafenib
according to local health authority approved label. It is
the aim of this observational cohort study to further
characterize safety and effectiveness of regorafenib in
routine clinical practice setting.
Healthcare resource utilization in the routine provision of
care is becoming increasingly important from a health
economics and outcomes research perspective.
Therefore, another aim of this observational cohort
study is to capture healthcare resource associated with
the management of treatment emergent adverse events
in the real world setting.
The primary objective of this study is to further
characterize safety of regorafenib use in routine clinical
practice settings.
The secondary objective of this study is to assess the
effectiveness of regorafenib in routine clinical practice
settings as measured by Overall Survival (OS),
Progression Free Survival (PFS) and Disease control
rate (DCR). Health Related Quality of Life (HRQoL)
Data will be collected in applicable countries.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator’s routine treatment practice to prescribe regorafenib.

  • - Patients participating in an investigational program with interventions outside of routine clinical practice

Trial summary

Enrollment Goal
1034
Trial Dates
April 2014 - November 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, France
Completed
Many Locations, Spain
Completed
Many Locations, Netherlands
Completed
Many Locations, Mexico
Completed
Many Locations, Austria
Completed
Many Locations, Taiwan
Withdrawn
Many Locations, Malaysia
Completed
Many Locations, Switzerland
Completed
Many Locations, Italy
Withdrawn
Many Locations, Canada
Withdrawn
Many Locations, Sweden
Completed
Many Locations, Denmark
Withdrawn
Many Locations, Norway
Completed
Many Locations, Czech Republic
Completed
Many Locations, Singapore
Completed
Many Locations, Luxembourg
Withdrawn
Many Locations, Belgium
Completed
Many Locations, Argentina
Withdrawn
Many Locations, Jordan
Withdrawn
Many Locations, Venezuela
Withdrawn
Many Locations, Saudi Arabia
Withdrawn
Many Locations, Kuwait
Withdrawn
Many Locations, Kazakhstan
Withdrawn
Many Locations, Lebanon
Withdrawn
Many Locations, Qatar
Withdrawn
Many Locations, United Arab Emirates
Withdrawn
Many Locations, Vietnam
Withdrawn
Many Locations, India
Withdrawn
Many Locations, Germany

Primary Outcome

  • Incidence of all treatment-emergent adverse events (TEAE) - Patients will be monitored for TEAE using the NCI-CTCAE Version 4.3
    date_rangeTime Frame:
    Up to 42 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Overall Survival (OS), OS is defined as the time interval from the start of regorafenib therapy to death, due to any cause.
    date_rangeTime Frame:
    Up to 42 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Progression free survival (PFS) is defined as the time interval measured from the day of start with regorafenib treatment to (radiological or clinical) progression or death, whichever comes first.
    date_rangeTime Frame:
    Up to 42 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Disease control rate (DCR) - DCR is defined as percentage of patients, whose best response was not progressive disease (i.e. CR, PR or SD). Stable disease must be at least 6 weeks in duration.
    date_rangeTime Frame:
    Up to 42 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Quality of Life - HRQoL using PRO questionnaire EQ-5D (8) in applicable countries
    date_rangeTime Frame:
    Up to 42 months
    enhanced_encryption
    Safety Issue:
    No
  • Healthcare resource utilization
    Hospitalization (Date, Length), Concomitant medication and procedures and any other anticancer therapies
    date_rangeTime Frame:
    Up to 42 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Correlate - Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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